June 28 (Bloomberg) -- MannKind Corp. won U.S. approval to
sell its inhaled insulin, culminating an almost decade-long
effort, with a warning that the product shouldn’t be used by
those with asthma or a serious lung disease.

The Food and Drug Administration said yesterday it cleared
MannKind’s Afrezza as a fast-acting insulin to be used at meal
times for those with Type 1 and Type 2 diabetes. The drug
labeling will warn that spasms in the airways of the lung have
been seen in patients with asthma and chronic obstructive
pulmonary disease and will advise against smokers using the
medicine, the agency said in a statement.

“It’s very gratifying,” Chief Financial Officer Matt
Pfeffer said in a telephone interview. “We’ve been working
toward this moment for a very long time, so we’re thrilled that
it’s here.”

Alfred Mann, MannKind’s 88-year-old founder and chief
executive officer, took the Valencia, California-based company
public in 2004. Since MannKind started late-stage clinical
trials eight years ago, the company’s share price has bounced
from a high of $21.70 to a low of $1.60, Pfizer Inc. pulled the
only inhaled insulin from the market and the FDA twice rejected
MannKind’s therapy, most recently in 2011, after the company
switched inhalers during the review process.

“It’s good news, and I consider the boxed warning to be a
non-event,” Keith Markey, a New York-based analyst at Griffin
Securities Inc., said in a telephone interview. “MannKind never
wanted to market it to people with COPD.”

Extended Trading

Shares of MannKind gained 10 percent to $11 in extended
trading at 6:56 p.m. New York time yesterday after falling 5.5
percent during regular trading to close at $10.

An estimated 25.8 million people in the U.S. have diabetes,
a condition in which insulin isn’t naturally produced or used
effectively by the body to break down sugar in the blood. The
illness can lead to heart disease, blindness and nerve and
kidney damage.

MannKind’s drug, a powder, is delivered through a cartridge
and is designed to control blood sugar during meal times in less
time than standard injections. The FDA said it doesn’t replace
long-acting insulin for Type 1 patients, whose bodies don’t
naturally produce insulin.